NMRC JA RD Project_GWU_PS_signed rev.2.pdf

J&A Number: NMRC

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION

1. Contracting Activity.

Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20901.

2. Description of the Action Being Approved.

Approval is requested to award a contract to pay the services provided by the following party:

GW Medical Service Associates, Department of Medicine, 2150 Pennsylvania Avenue, NW

Washington, DC 20037

Phone: 202.741.2222 Fax: 202.741.2185

3. Description of Supplies/Services.

The contractor shall provide the following services including shipping and handling of the final products to NMRC as described in the document Statement of Work section 2 quoted and highlighted as following:

GWU will provide samples which have been already collected and will continue conducting the prospective patient enrollment. GWU will collect serial samples at Day 0 (With fever in the last 7 days), Day 2, and convalescent (45-90 days after infection). Demographic data and clinical characteristics including warning signs, symptoms of severe dengue and results of diagnostic laboratories and clinically significant laboratory abnormalities and infection outcomes.

Requirement:

2.1 GWU will send samples collected in 2024-2025 by March/ April 2025 together with the related clinical and laboratory records. The expected number of subjects is >=30.

2.2 GWU will send samples collected in 2025 by Sep/ Oct 2025 together with the related clinical and laboratory records. The expected number of subjects is >=70.

2.3 GWU will send sample collected during 2025-2026 by Jun/Jul 2026. The expected number of subjects is >=100.

Note: Funding for 2.1 and 2.2 has been received. Funding for 2.3 has not been received and will be conditional based on funding.

The uniqueness of the service provider

Obtaining enough study subjects is the key for this proposal. Without the quantity and quality of the field samples, this study will fail.

In this study, the dengue cases will be grouped into three groups: dengue without warning sign (DENV-

WS), dengue with warning sign (DENV+WS), and severe dengue (SD) based on the WHO 2009 Dengue

Case Definition. Clinical endpoints such as plasma leakage, hemorrhage, and organ impairment

(including neurological, hepatic, or cardiac involvement), will be also used for data analysis and marker discovery. These endpoints reflect the disease burden and severity, and the requirement of medical attention.

The goal of the study is to discover biomarkers associated with Severe Dengue or with study endpoints reflecting the disease burden and the requirement of intense medical care. Although dengue infection is global, severe dengue is rare (<2%). Therefore, one of the biggest challenges of the study is the low occurrence of Severe Dengue. We have performed group size estimation using an online tool: Sample

Size Calculator. We selected a handful of markers (VACM-1, Ang-2, IP10, IL1R, CRP, CD62P, CD106, CD121b, and some other cytokine/chemokines) and extracted mean (median) and standard deviation for

SD/moderate dengue (or DHD/DSS) and dengue fever (or uncomplicated dengue) from publications and performed sample size calculation. We found that a group size of 300 will likely ensure the statistical significance for 85-90% markers. Therefore, we set the goal of obtaining a subject group of 300.

We discussed among the PIs of the field sites to increase the samples size. To achieve the goal of ~300 cases in a 2-year funding period, access to multiple hospitals in a highly endemic country is key.

Colombia has the highest rate of severe dengue fatality rate in the America in recent years.

The Colombian site, led by Dr. Aileen Chang, an Associate Professor of Medicine and Microbiology, Immunology and Tropical Medicine at George Washington University (GWU). Dr. Chang has been working in partnership with Colombian institutions for the last decade and has extensive experience executing observational and interventional clinical trials in Barranquilla, Colombia. In particular, she is currently working on a clinical trial in hospitalized patients in Colombia and has experience recruiting severe dengue cases. She has access to more than one hospital for patient enrollment.

4. Statutory Authority Permitting Other Than Full and Open Competition.

10 U.S.C. 2304(c)(1), 13.106-1 One source or limited sources.

5. Rationale Justifying Use of Cited Statutory Authority.

The contractor is the only one who has reliably responded to emails and expressed interest in providing the needed services with acceptable timeline for delivery.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Online for appropriate contractors:

Searching term: Commercial dengue patient samples

The search returned only one company: https://www.precisionformedicine.com/. We contact the company via email. No samples fit our study.

We therefore contacted our field collaborators who can perform prospective subject enrollment in

Colombia, Peru, and Thailand.

http://www.precisionformedicine.com/

Dr. Aillen Chang, a physician, and an associate professor at George Washington University School of

Medicine. Although Dr. Chang does not have archived samples, she has more than one enrollment hospitals to enroll patients. We selected her for the study site at Colombia.

Dr. Yupin Suputtamongkol, a professor and physician at Siriraj Hospital and Mahidol University, Thailand. Dr. Suputtamongkol can provide archived samples and can run prospective enrollment. We selected her for the study site of Thailand.

NAMRU-SOUTH: This site does not have hospital access required for this study. We did not choose this site.

7. Determination of Fair and Reasonable Cost.

Fair and reasonable determination will be made utilizing the Proposal analysis techniques described in

FAR 13.5

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Research was done by internet, emails, and TEAM meetings.

8. Other facts supporting the use of other than full and open competition.

If other suitable vendor(s) became available, a full and open competition may be considered.

9. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest for a full service expect the selected contractor, the University of Chicago.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

12. Point of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification is Priscilla Vania Harrison who may be reached at

(301) 319-3112.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Dr. Peifang Sun Phone Date

Project Principal Investigator

DSD/NMRC

Requirements Cognizance

HALL.ERIC.REE Digitally signed by

HALL.ERIC.REESE.1037970383

SE.1037970383 Date: 2025.02.19 10:25:59 -05'00'

Dr. Eric Hall Phone Date

Department Head

DSD/NMRC

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Deborah M. Sharpe Phone Date Contracting Officer

SUN.PEIFANG

Digitally signed by

.1269418318

SUN.PEIFANG.1269418318

Date: 2025.02.19 12:30:03

-05'00'

March 25, 2025301-319-9948